Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism

Obesity Clinical Trial

Official title:

Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06401161
• Other study ID #: LonggangDPHS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Longgang District People's Hospital of Shenzhen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the effect of Pu'er tea in overweight / obese patients with blood glucose or abnormal lipid metabolism. Compared with the effect of two Pu'er tea with different tea fuscin content in improving glucose and lipid metabolism, to investigate the mechanisms of bile acid metabolism and intestinal flora regulation.

In a prospective randomized controlled clinical study, 90 patients were divided into study group (3T Pu'er tea group, 45 patients) and control group ( traditional Pu'er tea group,45 patients). Before and after the treatment(0day, 12 weeks, 52 weeks) patients' markers of glucose and lipid metabolism were examined and compared.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

The A?B should be simultaneously met, or combined with the C?D?E.

1. 18-65 years, priority for patients over 30 years;

2. Overweight / obese patients: BMI =24 kg/m2.

3. Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;

4. Or combined with dyslipidemia: blood total cholesterol TC=6.4mmol/L or blood total triglyceride TG=2.0mmol/L or blood low-density lipoprotein LDL-C=3.1mmol/L;

5. Or with abnormal blood glucose:

• Impaired fasting glucose, IFG: fasting blood glucose was 6.1~<7.0mmol/L,and 2 hours after 75g oral blood glucose tolerance test(OGTT) <7.8mmol / L.

• Impaired glucose tolerance, IGT: the fasting blood glucose was <6.1mmol/L and 2 hours after 75gOGTT was 7.8~ <11.1 mmol / L;

• IFG with IGT: patients with both IFG and IGT;

• Patients with type 2 diabetes: random blood glucose 11.1mmol/L or fasting glucose of 7.0 mmol/L or 2 hours after OGTT.

Exclusion Criteria:

1. Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.

2. For women during pregnancy or lactation or with allergies;

3. Patients treated with any hypoglycemic drugs and insulin injections; regular or planned patients taking drugs that may affect glucose and lipid metabolism (as judged by clinicians, such as diet pills, lipid-lowering drugs) and liver protection drugs (as judged by clinicians);

4. Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;

5. Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;

6. Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;

7. Current smokers and regular drinking (excluding social drinkers only);

8. Yogurt intake within 1 week before the first visit and antibiotics within 3 months;

9. Drink strong tea regularly;

10. Participate in other clinical trials within 3 months;

11. Unable not cooperate with the investigator for other reasons.

12. Unfit for the researcherr.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• 3T Pu'er tea
Two types of Pu-erh tea with different levels of theabrownin content.

Locations

Country	Name	City	State
China	Longgang District People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Longgang District People's Hospital of Shenzhen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	0week
Primary	Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	6weeks
Primary	Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	12weeks
Primary	Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	52weeks
Primary	Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range:Fasting Blood Glucose 3.9-6.1 mmol/L.	0week
Primary	Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range:Fasting Blood Glucose 3.9-6.1 mmol/L.	6weeks
Primary	Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range:Fasting Blood Glucose 3.9-6.1 mmol/L.	12weeks
Primary	Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range:Fasting Blood Glucose 3.9-6.1 mmol/L.	52weeks
Primary	Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	0week
Primary	Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	12weeks
Primary	Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	52weeks
Primary	Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	0week
Primary	Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	12weeks
Primary	Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	52weeks
Secondary	Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Creatinine: Female 44-97umol/L, Male 53-106umol/L.	0week
Secondary	Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Creatinine: Female 44-97umol/L, Male 53-106umol/L.	12weeks
Secondary	Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Creatinine: Female 44-97umol/L, Male 53-106umol/L.	52weeks
Secondary	Bone densitometry	The bone mineral density of the axial skeleton (L1-4 vertebrae, left femoral neck, total hip) of the subjects was measured in g/cm2 using a dual-energy X-ray absorptiometry (coefficient of variation <1%) from Hologic, USA.	0 week
Secondary	Bone densitometry	The bone mineral density of the axial skeleton (L1-4 vertebrae, left femoral neck, total hip) of the subjects was measured in g/cm2 using a dual-energy X-ray absorptiometry (coefficient of variation <1%) from Hologic, USA.	52 weeks
Secondary	Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Alanine aminotransferase: 0-40U/L.	0week
Secondary	Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Alanine aminotransferase: 0-40U/L.	12weeks
Secondary	Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range:Alanine aminotransferase: 0-40U/L.	52weeks